NA

Additional Manufacturer Narrative

THE POWERLIFT STIRRUPS SUBJECT OF THE REPORTED EVENT WERE RETURNED TO THE SUPPLIER FOR EVALUATION. THE SUPPLIER'S EVALUATION FOUND NO ISSUE WITH THE FUNCTION OR OPERATION OF THE STIRRUPS; THE REPORTED EVENT COULD NOT BE DUPLICATED. THE POWERLIFT STIRRUPS INSTRUCTIONS FOR USE STATES, "THE BOOT HAS A SELF-ADJUSTING DESIGN TO PROTECT THE CALF DURING RAISING OR LOWERING OF THE LEGS. IT IS FREE FLOATING AND MOVES WITH THE PATIENT'S LEG AS NEEDED." A STERIS ACCOUNT MANAGER PERFORMED IN-SERVICE TRAINING WITH USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE STIRRUPS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

INVESTIGATION IN PROGRESS. THE DEVICES SUBJECT OF THE REPORTED EVENT ARE BEING RETURNED FOR EVALUATION (SERIAL NUMBERS (B)(6)). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR POWERLIFT PLUS STIRRUPS WOULD NOT REMAIN IN THE LOCK POSITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT REPORT OF DELAY. NO REPORT OF INJURY.